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临床试验/NCT05590767
NCT05590767已完成不适用

Department of Anesthesiology, Tri-Service General Hospital and National Defense Medical Center , Taipei, Taiwan

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Pupillary Pain Index (PPI )

研究概览

简要总结

When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique manner known as Pupil reflex dilation (PRD).The degree of pupillary reflex dilatation can be further quantified into an objective parameter, termed the Pupillary pain index (PPI), as a monitoring tool for the balance between nociception and antinociception in surgical patients The motivation for this study is to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery. The purpose of the study is as follows: (1) Can PDR in patients undergoing general anesthesia be used to assess the analgesic effect of interscalene block? (2) Does PPI at the end of surgical anesthesia in such patients correlate with the first numerical pain scale (NRS) during the recovery room?

详细描述

When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique way called pupillary reflex dilation (PRD), which can be observed both when the individual is awake or under anesthesia. The degree of pupillary reflex dilatation can be further quantified into an objective parameter called the Pupillary pain index (PPI), which serves as a monitoring tool for the balance between nociception and antinociception in surgical patients. Larson studied 32 female breast surgery patients who received general anesthesia combined with thoracic paravertebral nerve block on the affected side. The results showed that the affected side of the nerve block had significantly lower pupillary reflex dilation than those without nerve block on the healthy side of the breast. The authors believed that this study confirmed the value of pupillary reflex dilation in monitoring the success rate of unilateral thoracic paravertebral nerve block during general anesthesia. In a prospective observational study of 26 patients undergoing neurosurgery under general anesthesia, Pupillary pain index at the end of surgical anesthesia and Numerical Rating Scale (NRS) during the recovery room were recorded separately, The results showed a significant correlation between the two parameters (rS = 0.62; P = 0.002). The authors concluded that the application of the measurement of pupillary reflex dilation may be useful in predicting and preventing acute postoperative pain. Shoulder rotator muscle repair is a common surgery in our hospital. Patients must receive general anesthesia, sometimes combined with scalene interscalene block (ISB), to improve postoperative acute pain ,help to perform passive shoulder rehabilitation exercises and prevent shoulder joint adhesions. Based on the above literature review, the motivation for this study was to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery. The objectives of the research project are as follows: 1. Can pupillary reflex dilation in patients undergoing general anesthesia be used to assess the analgesic effect of scalene nerve block? 2. Is the pupillary pain index (PPI) at the end of surgical anesthesia correlated with the first numerical pain scale (NRS) during the recovery room in such patients?

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received general anesthesia combined with ipsilateral interscalene block
  • Patients listed as a Class I/II physical condition of the American Society ofAnesthesiologists

排除标准

  • Patients younger than 20 years of age
  • The presence of ophthalmologic (recent eye surgery or cataracts) or neurologic diseases (diabetic neuropathy,or postherpetic neuralgia) that could interfere with Pupillometer

结局指标

主要结局

Pupillary Pain Index (PPI )

时间窗: After induction of anesthesia and before surgical incision

The primary outcome is the difference of the pupillary pain index (PPI ) between the ISB side and the control side The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI .

次要结局

  • Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)(From emergency of anesthesia to early Post-anesthesia period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lu Yihsiung

Attending doctor, Department of Anesthesiology

Tri-Service General Hospital

研究点 (1)

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